A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application

A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®

The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.

Healthy Male Subjects:

Inclusion:

• Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

• Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Healthy Female Subjects:

Inclusion:

• Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

• Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.